Multicenter, interventional, single-arm, phase IV study evaluating tolerability of Eribulin and its relationship with a set of polymorphisms in an unselected population of female patients with metastatic breast cancer

• Conditions: Patients with metastatic breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004600-19-IT
• Lead Sponsor: Azienda Ospedaliera Fatebenefratelli e Oftalmico - Milano, Italy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-09
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
1.Female patients =18 years
2.Diagnosis of metastatic breast cancer
3.Previous treatment with anthracyclines and taxanes
4.Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication
5.Ability to comply with sample collection
6.Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.
7.Absence of any contraindication to treatment as in sections Contraindication” Special warning” and Interaction with other medicinal product” of the Summary of product characteristics (SPC).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The presence of any of the following will exclude a subject from study enrollment:
1.Previous treatment with Eribulin in a previous line of treatment
2.Previous treatment with Eribulin off label

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is primarily aimed at surveying the tolerability profile of Eribulin in an unselected population of patients with MBC in relation to toxicities already described in clinical trials, and neurotoxicity in particular. ;Secondary Objective: The secondary objectives of this trial include:<br>•To study the relationship between specific genetic polymorphism and incidence and severity of peripheral neuropathy<br>•To describe treatment efficacy in terms of duration of treatment and impact on survival.<br>;Primary end point(s): 1.Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade), especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropoenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.<br>;Timepoint(s) of evaluation of this end point: During the treatment untill 30 days after treatment discontinuation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy <br>-Evaluation of quality of life during treatment using EORTC QLQ-C30 and QLQ-BR23 questionnaires.<br>-Assessment of dose intensity and dose schedule maintenance.<br>-DOT (Duration Of Treatment) and OS (Overall Survival).<br>;Timepoint(s) of evaluation of this end point: During the treatment, untill 30 days after treatment discontinuation and untill death